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TigerPaw System II

Patients with unnatural heart rhythm, otherwise known as atrial fibrillation, may undergo treatment with a Tigerpaw II medical device. The device assists with open heart surgery by helping prevent blood clots. However, the Tigerpaw is associated with tearing the atrial wall and causing bleeding.

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The TigerPaw II is a medical device sometimes used in open heart surgery, when patients have been diagnosed with atrial fibrillation (AFib), an irregular, unnatural heart rhythm. 1 This device is a type of surgical fastener or stapler used to seal off a specific area of tissue in the upper left chamber of the heart called the left atrial appendage, or LAA. 2

Device for Treating Atrial Fibrillation

In patients who have been diagnosed with atrial fibrillation, the steady rhythm of the heart’s two upper chambers (atria) becomes irregular, sometimes beating very quickly and chaotically. This unnatural rhythm is called “fibrillation.” 3

In atrial fibrillation, blood collects in the atria without moving efficiently into the heart’s two lower chambers (ventricles) in a healthy and natural way. Sometimes, as a result of atrial fibrillation, blood clots can form in the atria. 4

Some people who have been diagnosed with this condition don’t feel any symptoms. Others may experience palpitations, chest pain or shortness of breath. Individuals with this condition face an increased risk of stroke because blood clots have the potential to move from the heart to the brain and create a blockage. 5

TigerPaw System II and AFib

During heart surgery, doctors may perform a specific surgical procedure with the intention of inhibiting future blood clots from forming in the heart. One of the most common places for clots to pool is in the left atrial appendage, a small sac in the heart muscle’s wall.  A left atrial appendage closure may be performed to seal off the LAA and prevent blood clots from collecting there. 6

One such device used in this type of surgery is the TigerPaw System II, manufactured by LAAx, Inc., which was acquired by Maquet Medical Systems in 2013. 7 The TigerPaw System II device was indicated to close off the small left atrial appendage.

Recall of TigerPaw System II

On March 25, 2015, however, LAAx, Inc., and Maquet initiated a voluntary recall of  the TigerPaw System after several reports where tearing of the atrial wall and bleeding were described, potentially due to the incomplete closure of the TigerPaw System II fastener. On March 30, 2015, an urgent letter was sent out instructing all affected customers to “remove, quarantine, and place recalled devices in a secure location.” 8

Shortly thereafter, on April 23, 2015, the FDA categorized this recall as a Class 1 recall of the TigerPaw System II. Approximately 4,150 of these devices have been recalled in the U.S. 9

An FDA Class 1 recall is the most serious type of recall the FDA issues. Class 1 recalls signify the potential for the device to have very serious negative health consequences or even cause death. 10

  1. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm446116.htm; http://www.medscape.com/viewarticle/843750; http://www.prnewswire.com/news-releases/maquet-cardiovascular-acquires-laax-inc-and-its-tigerpaw-system-ii-occlusion-device-to-expand-cardiac-surgery-offering-208282991.html; http://www.nhlbi.nih.gov/health/health-topics/topics/af 

  2. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=135185; http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm446116.htm 

  3. http://www.nhlbi.nih.gov/health/health-topics/topics/af 

  4. http://www.nhlbi.nih.gov/health/health-topics/topics/af 

  5. http://www.nhlbi.nih.gov/health/health-topics/topics/af 

  6. http://www.mayoclinic.org/diseases-conditions/deep-vein-thrombosis/in-depth/warfarin-side-effects/art-20047592 

  7. http://www.prnewswire.com/news-releases/maquet-cardiovascular-acquires-laax-inc-and-its-tigerpaw-system-ii-occlusion-device-to-expand-cardiac-surgery-offering-208282991.html 

  8. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm446116.htm 

  9. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm446116.htm; http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=135185 

  10. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm446087.htm